Interest of the Study of Electroencephalogram and Peripheral Vegetative Markers for the Evaluation of Nociception Under General Anesthesia.

NCT03994887 | Withdrawn

• 2 other identifiers: 18CH1682019-A00201-56
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia (GA) is a state of loss of consciousness induced by anesthetic products. In a GA, two classes of products are usually used: on the one hand, hypnotics that are responsible for the sleep component (hypnosis) and memory loss (amnesia), and on the other hand opioids that have an analgesic role. The doses of hypnotic and morphine necessary to achieve this state of loss of consciousness and lack of response to painful stimulation vary from subject to subject, and during surgery depending on the intensity of the stimulus, requiring permanent adaptation to avoid overdose or underdosing, responsible for morbidity. Several monitors of the hypnotic component have been developed in recent years, which can now be used routinely, such as the Bispectral Index (BIS) or Spectral Entropy. However, there is currently no clinically validated technique for monitoring pain or the effect of opioids in the operating room. Spectral analysis of the electroencephalogram (EEG) revealed a significant decrease (-30%) in alpha spectral power, observed specifically in painful experimental conditions in healthy awake subjects. On the other hand, a painful experience is accompanied by transient changes in various parameters under vegetative control, whether cardiovascular, cutaneous or pupillary, essentially underpinned by the activation of the sympathetic system. The investigators hypothesize that a real-time dynamic analysis of the spectral power of EEG combined with that of cardiovascular vegetative parameters, cutaneous conductance and pupillary diameter is likely to be a marker of nociception under GA.

Conditions

General Anesthesia

Keywords

General anesthesia; Surgery; Free Head

Outcome Measures

Primary Outcomes (1)

• ElectroEncephaloGram (EEG) Alpha spectral power

  variations of the EEG parameters (spectral power of the alpha rhythms), during nociceptive stimuli performed under AG at constant hypnosis depth (BIS between 50 and 60), without and after injection of a standardized dose of morphine (0.2 μg / kg of sufentanil based on the theoretical weight) of the patient).

  1 day

Secondary Outcomes (4)

• Beta spectral power

  1 day

• gamma spectral power

  1 day

• delta spectral power

  1 day

• theta spectral power

  1 day

Other Outcomes (4)

• Low frequency spectral power

  1 day

• High frequency spectral power

  1 day

• Cutaneous conductance

  1 day

Study Arms (1)

Experimental group

EXPERIMENTAL

Patients under general anesthesia will be included.

Device: Experimental group

Interventions

Experimental group DEVICE

EEG acquisition system BioSemi (Amsterdam, the Netherlands), enabling real-time measurement and continuous recording of EEG on up to 128 leads.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient affiliated or entitled to a social security scheme
• Over 18 years old
• To be operated on a regulated surgery allowing access to the head and to one eye, under AG, in the operating theater of the CHU of Saint-Etienne
• And having given his free, informed, written and signed consent.

You may not qualify if:

• Subject to a measure of legal protection (tutelage, guardianship)
• Admitted for emergency surgery
• With known allergy to any of the anesthetic agents used in the study
• Having been asleep under general anesthesia in the 7 days preceding the intervention
• A pacemaker or heart transplant patient
• With a history of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomia stage
• With psychiatric history or severe depression
• Presenting a peripheral or central neurological pathology that may modify the physiological responses to nociceptive stimulation
• With abnormal heart rhythm (atrial fibrillation or frequent extrasystoles)
• Treated for arterial hypertension with angiotensin type 2 receptor antagonists
• Treated with anti-arrhythmic, α- or β-blocking, which would make the interpretation of the results more difficult
• With chronic pain
• Treated with morphine or long-term neuroleptic
• Consuming cannabis or another narcotic
• Presenting bilateral ocular pathology that may interfere with pupillary dilatation

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Study Officials

• DAVID CHARIER, MD

  CHU DE ST ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a monocentric and prospective observational study on the physiology of nociception under general anesthesia. The patient will be his own witness.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 21, 2019
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)